ACA (R) DIGITOXIN CALIBRATOR
Device Facts
| Record ID | K891093 |
|---|---|
| Device Name | ACA (R) DIGITOXIN CALIBRATOR |
| Applicant | E.I. Dupont DE Nemours & Co., Inc. |
| Product Code | DCJ · Immunology |
| Decision Date | Apr 26, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5160 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A beta-globulin immunological test system is a device that consists of reagents used to measure by immunochemical techniques beta globulins (serum protein) in serum and other body fluids. Beta-globulin proteins include beta-lipoprotein, transferrin, glycoproteins, and complement, and are rarely associated with specific pathologic disorders.
